Some surgical procedures, such as those involving installation of a joint prosthesis, rely on the use of components that must be securely attached to other components, such as a prosthetic device or to bony anatomy. If, in attaching a component, the component is either oversecured or undersecured, there can be associated negative effects. For example, an undersecured component may loosen, while an oversecured component may impart an undesirable amount of stress to one or both of the components, including component fracture and/or striping of the drive feature or threaded attachment.
Normally, the attachment of an implant component to another implant component and/or to a prosthetic device is done using devices and methods that impart assembly torque throughout the attachment process. A certain level of torque is required to properly secure a component, sometimes referred to as a driven member. To assist operators in being able to perceive when the proper level of torque has been imparted on the driven member, devices have been developed to help ensure that a consistent and/or limited amount of torque is imparted on the driven member to properly secure torque-applied components to other components or bony anatomy. Among these devices are torque-limiting drivers that are calibrated to impart a desired level of torque to a component during the attachment of the component to another component such as a prosthetic device.
Torque limiting drivers, however, can suffer from some notable complications. For example, driver tip failures are the subject of frequent complaints, as documented in the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Driver tip failures can result in an insufficient or excessive amount of torque being applied, and can also lead to unplanned implantation of the driver tip in the body after failure has occurred. For example, if a driver tip or breakaway implant is configured to fail by fracturing after a desired torque level is achieved, the rough surfaces at the fracture can cause undesirable harm to tissue at the surgical site, or elsewhere in the body if the tip is not retrieved. Additionally, if the portion of the fractured tip is left engaged with the driven member, additional torque cannot be applied to the driven member because the fractured tip prevents engagement by a new driver tip. If a driver tip fails and it is retrieved, such retrieval is typically done manually. Likewise, if a new tip is required for further torque application, it is also typically attached manually. This can lead to the driver being frequently inserted and removed from the body, thereby increasing the risk of infections and other complications. Still further, existing torque limiting drivers can also have inconsistencies following manufacturing, reuse, cleaning, and reprocessing. New more aggressive cleaning materials and requirements can decrease the cost effectiveness and reliability of a reusable torque limiting driver.
It is therefore desirable to provided devices, systems, and methods that improve the consistency and reliability of torque limiting drivers and reduce the risks associated with driver tip failures.